The recent legal wrangling regarding the use or prohibition of the use of federal funds in scientific research utilizing human embryonic stem cells (hESCs) has generated significant uncertainty in the stem cell research community and is very unfortunate. The ruling places current hESC research in jeopardy and casts a cloud over future projects.
Congress should pass legislation to reverse this ruling and permit funding for hESC science. Even though the research community is moving toward the human induced pluripotent stem cell (iPSC) model introduced in 2007 by James Thomson, V.M.D., Ph.D., and Shinya Yamanaka, M.D., Ph.D., hESCs still retain utility as a benchmark for pluripotency and for differentiation protocols.
Under the hESC ban instituted by the Bush administration, federally funded research could continue on hESC lines that had been developed before August 2001, but federal funding of research on new hESC lines was prohibited.
The recent U.S. District Court decision, based on the Dickey-Wicker Amendment that Congress adds to budget legislation each year, is much more expansive. It prohibits federal funding of research on any hESC line regardless of when it was developed.
Ultimately, if the ban is not overturned by Congress or upon appeal to the U.S. Court of Appeals or the U.S. Supreme Court, then federally funded hESC research is in danger of grinding to a halt.
Numerous research projects will have to be redesigned or shut down. hESCs are the current stem cell benchmark for pluripotency to which all stem cell models are currently compared. At this time, hESCs are the stem cell benchmark for pluripotency to which all stem cell models are compared, and thus the lack of new hESC lines will ultimately inhibit progress of our understanding of pluripotency.
In addition, the ban could have a negative impact on the development of stem cell therapeutics since virtually all in development today are hESC-based. Thus the ban could potentially slow the development of important new therapeutic breakthroughs.
How does the ruling, if affirmed by a higher court, impact companies developing hESC-based products? hESC research will be able to proceed for now in instances where it is not directly federally funded. However, much hESC-based therapeutic R&D is based on the accumulated knowledge from federally funded basic research. Eventually, if the funding ban continues, then the decline on the rate of accumulation of new information on stem cell biology will begin to be a drag on therapeutic stem cell development as well.